Data / Medical devices / United States / PREAT Corporation
PREAT Corporation: FDA-registered device maker in Santa Maria, CA, United States, 25 510(k) clearances
PREAT Corporation is registered with the FDA (registration 2918719) in Santa Maria, CA, United States. It lists 15 device types. The FDA files 25 510(k) clearances under its listings, the newest dated April 16, 2026. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2918719
- Address
- 2625 Skyway Drive Suite B, Santa Maria, CA, United States, 93455
- Owner or operator
- Young Innovations Inc (2918719)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- July 23, 1986
- Registered through
- 2026
- Brand names listed
- Cuff Height Measuring Tool, Implant Prosthetic Components, Implantlink Tips, Preat Abutments, PreatLoc
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 16, 2026 | K253804 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | accessdata.fda.gov |
| October 31, 2025 | K251547 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | accessdata.fda.gov |
| May 8, 2025 | K243824 | Preat Abutments | NHA | Substantially Equivalent | Preat Corporation | accessdata.fda.gov |
| November 5, 2024 | K242340 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | accessdata.fda.gov |
| October 27, 2022 | K222288 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | accessdata.fda.gov |
| October 26, 2022 | K220823 | Preat Abutments | NHA | Substantially Equivalent | Preat Corporation | accessdata.fda.gov |
| March 11, 2022 | K212628 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | accessdata.fda.gov |
| November 10, 2019 | K191986 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | accessdata.fda.gov |
| March 18, 2019 | K183518 | Preat Abutments | NHA | Substantially Equivalent | Preat Corporation | accessdata.fda.gov |
| April 9, 2018 | K171409 | OT EQUATOR | NHA | Substantially Equivalent | Rhein'83 Srl | accessdata.fda.gov |
| August 8, 2017 | K170588 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | accessdata.fda.gov |
| June 6, 2017 | K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| December 14, 2016 | K160475 | Ritter Dental Implant System | DZE | Substantially Equivalent | Ritter Implants GmbH & Co. KG | accessdata.fda.gov |
| November 25, 2015 | K142211 | OT EQUATOR | NHA | Substantially Equivalent | Rhein'83 Srl | accessdata.fda.gov |
| October 7, 2015 | K151375 | Inclusive Titanium Abutments compatible with: Hiossen HG Implant System | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| October 1, 2015 | K143515 | Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| April 2, 2015 | K143353 | Hahn Tapered Implant System | DZE | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| January 6, 2015 | K141923 | INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| November 25, 2014 | K142118 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| November 13, 2014 | K142115 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| February 22, 2013 | K121406 | INCLUSIVE TAPERED IMPLANT SYSTEM | DZE | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| December 10, 2012 | K121391 | INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| October 12, 2012 | K121688 | MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| December 28, 2010 | K100993 | INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS | NHA | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
| April 21, 2004 | K033630 | MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK | DZE | Substantially Equivalent | Rhein 83 Srl | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 25, 2025 | 97239 | Class II | Ongoing | NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662 | Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay. | accessdata.fda.gov |
| June 24, 2025 | 97136 | Class II | Ongoing | Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only | Due to manufacturing error, digital analog rotational feature is 180 degrees off. | accessdata.fda.gov |
| April 2, 2025 | 96671 | Class II | Ongoing | Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support fo | Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant. | accessdata.fda.gov |
| June 25, 2024 | 94933 | Class II | Ongoing | Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, | Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations. | accessdata.fda.gov |
| April 10, 2024 | 94693 | Class II | Ongoing | 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation. | Due to incorrect milled titanium abutment being packaged and labeled. | accessdata.fda.gov |
| February 9, 2024 | 94032 | Class II | Ongoing | Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967 | Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant. | accessdata.fda.gov |
| July 18, 2023 | 92867 | Class II | Ongoing | Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental | The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage | accessdata.fda.gov |
| February 21, 2023 | 91876 | Class II | Ongoing | Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 | Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient. | accessdata.fda.gov |
| February 1, 2023 | 91614 | Class III | Ongoing | PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue. | Product is labeled with an incorrect expiration date. | accessdata.fda.gov |
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Updated April 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.